Active Ingredients:
Methyl Salicylate 10%
Methylten Cream
FDA Label NDC 59088-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Methylten (NDC 59088-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, purpose:, uses:, warnings:, otc - keep out of reach of children, when using this product, stop use and ask doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Topical Analgesic
Uses:
For the temporary relief of minor aches and pains of muscles and joints.
Warnings:
■ For External Use Only
Otc - Keep Out Of Reach Of Children
■ Keep this and all other drugs out of the reach of children.
When Using This Product
■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or broken skin ■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Stop Use And Ask Doctor If
■ pain persists for more than 7 days, redness is present or in conditions affecting children under 12 years of age. ■ excessive irritation of the skin develops. ■ if pregnant or breastfeeding ■ ask a health professional before use.
Directions
■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician
Other Information
■ store between 20° to 25° C (68°- 77° F)
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Borago Officinalis (Borage) Seed Oil, Carbomer. Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol , Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Fragrance.
Methyltentm
Manufactured by:
PureTek Corporation
Panorama City, CA 91402
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877-921-7873
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